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The ever-changing demands of serialization

The ever-changing demands of serialization

Are CDMO’s prepared for the new regulations? 

Drug counterfeiting is a serious problem facing the industry and one that continues to grow unabated worldwide. Regulatory agencies have been seeking and implementing new methods to thwart drug counterfeiters, relying on a clear means of verification and identification known as serialization. Today, serialization of packaging is considered one of the most effective solutions by many countries. Beginning this year, agencies from many countries will be tightening their guidelines in order to fight drug counterfeiting and are relying on serialization to do so. In some countries like Turkey, India and Argentina, regulators are already demanding that drugs be serialized. The EU will do so in 2019. Beginning November 2017, the FDA will make serialization of drugs a requirement, with drugs being given a national drug code (NDC), a serial number, a batch number and a sell-by date. Because serialization requirements differ among countries, pharmaceutical and biotech companies must find flexible solutions that can easily adapt to the demands of individual regulatory authorities.

What are some of the challenges to being prepared for new serialization regulations and how are companies such as Vetter doing so? Bernd Stauss, Senior Vice President Production/ Engineering for Vetter gives his insight into new, important regulations and what Vetter is doing to not only help its customers meet the new guidelines, but help them beat the counterfeiters at their own game. 

There is a perception that the industry may not be prepared for the regulations regarding serialization. How is Vetter preparing for the new regulations?

We cannot comment on what others are doing. However, I can say that Vetter has long been preparing for new regulations, having established the basis for serialization as early as 2012 when we started a systematic process prior to official regulatory deadlines. Our project began as a concept study where we examined what the nature of our overall plan was, what lines needed to updated first, which suppliers would we work with, what were the costs involved, and what staff members should be included as part of the project team.

Only after carefully and thoroughly answering these questions could we begin our serialization project. This included upgrading of our systems and then implementing the pilot line, which was already validated. Our efforts led to our first customer project. Today, we are compliant with serialization requirements for many different markets and are systematically upgrading further lines. 

Planning and preparation for the proper implementation of serialization is essential for success, but experience is priceless. Does Vetter have experience with the implementation of customer projects?

As stated, Vetter has been preparing for serialization regulations for quite some time and is already compliant with serialization requirements for different markets. In 2014, for example, we successfully implemented our IT-solution and began offering our customers a range of serialization services. That same year Vetter announced significant progress in our solution for state-of-the-art packaging, designed to support the prevention of product counterfeiting. In 2015, we reported the first commercial batches with single-use identification numbers for one of the world’s leading pharmaceutical companies to South Korea. We have also been working on and preparing for serialization requirements in the US in 2017 and the EU in 2019 and are already prepared for other regions of the world such as China, Brazil and Columbia. 

There appears to be continuous change in the timelines of regulatory requirements for serialization. For example, China and Brazil have put their regulations on hold. What effects do such changes have on the development of the serialization program at Vetter, and what is Vetter doing to anticipate and meet the future demands of international serialization regulations?

Risking the possibility that regulations will be put on hold and not taking an action is not an approach Vetter would ever be comfortable taking. We have been in position to support customer and regulatory serialization demands in the best way possible for some time now. To achieve this, we prepare early, creating partnerships and working as close as possible with our customers so that the regulatory requirements can be fulfilled according to the prescribed timeline of the authority. Vetter already has an IT solution to support serialization, lines to print and encode serialization data on packages, and the ability to manufacture products that are serialized according to the latest regulatory guidelines. As counterfeiting continues to grow, regulatory authorities are increasingly relying on serialization, demanding that the smallest saleable packaging unit be marked with a single-use identification number. That is why the increase of the serialization capacities is crucial, and why our next steps are to continuous invest in this service offer. 

Vetter appears to be a pioneer among CDMO’s in meeting serialization requirements with successfully completed customer projects, and future planning in place to both increase serialization capacity while meeting future serialization requirements. What are the main aspects Vetter must consider when realizing a successful serialization project for your customers?

To ensure that the serialization process is well established, Vetter created a Serialization Process Manager function responsible for ensuring that all future requirements arising from different markets will be successfully implemented. Of course, you will need to continue to build up your knowledge of the serialization requirements and remain abreast of any new regulatory requirements. It is essential to keep the customer’s needs in mind, combining the regulatory requirements with the customer specific requirements. Balance between the two is the goal.

To achieve this, we began with a carefully defined serialization strategy and then created a cross-functional team that includes experts with knowledge of serialization background. The team includes members from departments such as IT, Product Management, Regulatory Affairs, Project Management, Engineering, and Supply Chain. 

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Vetter is a global CMO for aseptic fill & finish contract manufacturing


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